Product Wiki · Recalls · U.S. FDA — Device Enforcement

Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838 — recall Z-1362-2022

U.S. FDA — Device Enforcement · United States · 2022-05-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1362-2022
Date of alert
2022-05-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Cook Incorporated
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00827002028388
Reported risk: The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or particulate entering the bloodstream which may result in pulmonary embolism or ischemia.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.